The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03748836




Registration number
NCT03748836
Ethics application status
Date submitted
5/11/2018
Date registered
21/11/2018
Date last updated
13/03/2019

Titles & IDs
Public title
Adult Healthy Volunteers Study to Evaluate ALPN-101 Safety
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-101 in Adult Healthy Volunteers
Secondary ID [1] 0 0
AIS-A01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALPN-101
Treatment: Drugs - Placebo

Active Comparator: Single Ascending Dose ALPN-101 -

Placebo Comparator: Single Dose Placebo -

Active Comparator: Multiple Ascending Dose ALPN-101 -

Placebo Comparator: Multiple Dose Placebo -


Treatment: Drugs: ALPN-101
Single or multiple doses of ALPN-101 delivered via intravenous or subcutaneous injection. Ascending dose levels will be evaluated.

Treatment: Drugs: Placebo
Single or multiple doses of placebo delivered via intravenous or subcutaneous injection, matched to ALPN-101 cohorts.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety, as assessed by adverse events according to CTCAE v5.0 - The rate of adverse events will be compared between the 2 treatment groups.
Timepoint [1] 0 0
From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4-8 weeks)
Secondary outcome [1] 0 0
Pharmacokinetics of ALPN-101 as assessed by time of maximum ALPN-101 concentration. - Plasma levels of ALPN-101 will be serially evaluated following dosing of study drug, and the time of maximum plasma concentration (Tmax) will be identified.
Timepoint [1] 0 0
From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)
Secondary outcome [2] 0 0
Pharmacokinetics of ALPN-101 as assessed by the maximum concentration of ALPN-101. - Plasma levels of ALPN-101 will be serially evaluated following dosing of study drug, and the maximum plasma concentration (Cmax) will be calculated.
Timepoint [2] 0 0
From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)
Secondary outcome [3] 0 0
Pharmacokinetics of ALPN-101 as assessed by AUC on all subjects. - Plasma levels of ALPN-101 will be serially evaluated following dosing of study drug, and the area under the curve (AUC) will be calculated.
Timepoint [3] 0 0
From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)
Secondary outcome [4] 0 0
The incidence of ADA against ALPN-101 will be assessed and summarized. - The incidence of ADA against ALPN-101 will be assessed by the percentage of patients with a positive ADA result of all the treated patients.
Timepoint [4] 0 0
From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)

Eligibility
Key inclusion criteria
1. Able to participate and willing to give written informed consent.

2. Healthy adult participant 18 to 65 years of age, inclusive, at the time of informed
consent.

3. BMI between 18 and 30 kg/m2, inclusive.

4. Male participants must agree to use a highly effective method of contraception
consistently and correctly during the treatment period and for at least 30 days after
the last dose of study intervention and to refrain from donating sperm during this
period.

5. Female participants must not be pregnant or breastfeeding
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Health Exclusions

6. Any concomitant disease, condition or treatment that could interfere with the conduct
of the study or that would, in the opinion of the Investigator or Sponsor, pose an
unacceptable risk to the participant in the study or interfere with the interpretation
of study data.

7. History or symptoms of significant psychiatric disease in the opinion of the Principal
Investigator, including but not limited to depression and schizophrenia.

8. History of immunological disorders, auto-immune disorders, acquired or congenital
immune deficiency.

9. History of significant hepatic or renal disease or impairment.

10. Evidence of an active or suspected cancer or a history of malignancy within the
previous 3 years, except for the following, which did not require systemic therapy and
are considered cured: nonmelanoma skin cancer, curatively treated localised prostate
cancer or other in situ cancer.

11. History of major organ transplantation with an existing functional graft. Therapeutic
and Intervention-Related Exclusions

12. Use of prescription medications or herbal remedies within 14 days or 5 elimination
half-lives (whichever is longer) of study intervention administration or use of
over-the-counter medications (OTC) within 7 days of study intervention administration
(apart from recommended doses of vitamin/mineral supplements, OTC analgesics, etc.,
approved by the Investigator and Sponsor). Participants who have been on hormone
replacement therapy (HOURST) for a period of at least 2 months will not be excluded
from the study, provided the HOURST regimen remains unchanged during the conduct of
the study.

13. Any concomitant medications that prolong QT/QTc interval.

14. Dosed with an investigational drug within 30 days or 5 elimination half-lives
(whichever is longer) prior to study drug administration.

15. Received any systemic steroid within 1 month or systemic immunosuppressant agent
within 6 months prior to study drug administration.

16. Received any antibody therapy or biologic products within 6 months prior to study drug
administration.

17. Significant loss of blood including blood donation over 500 mL or transfusion of any
blood product within 3 months before the Screening Visit.

18. Unwilling to refrain alcohol use 48 hours prior to your admission into the clinical
research unit.

19. Known hypersensitivity, allergy or intolerance to the study drug or any of the
excipient contained in the intervention formulation.

20. Immunisation with any vaccine within 6 weeks prior to study drug administration.

21. For participants enrolled in cohorts in which KLH will be administered: known
administration of KLH within 6 months prior to study drug administration; known
seafood or shellfish allergy, or known hypersensitivity or allergy to KLH Laboratory
Exclusions

22. Any clinically significant (at the discretion of the Investigator) abnormalities in
laboratory test results, including complete blood count, chemistry panels and
urinalysis. If out of range at the Screening Visit and/or admission to the CRU and
deemed clinically significant by investigator, the tests may be repeated once on a
separate day.

23. Estimated creatinine CL < 90 mL/minute at the Screening Visit

24. Positive test at the Screening Visit and/or at baseline for drugs of abuse (e.g.,
phencyclidine, opiates, benzodiazepines, barbiturates, amphetamines, methamphetamines,
cocaine and THC). The repeat test is permitted once for a suspected false positive
test.

25. Positive alcohol breath test at the Screening Visit and/or at baseline.

26. Positive result on tests for HIV-1 and/or HIV-2 antibody, anti-hepatitis B virus
antibodies (core antibody [HBcAb], surface antigen [HBsAg]) or anti-hepatitis C virus
antibody.

27. Positive serum pregnancy test at the Screening Visit or admission to the CRU.
Infection-related Exclusions.

28. Acute infection including viral infections in the preceding 6 weeks

29. History or presence of any chronic infectious condition, including but not limited to
tuberculosis or parasitic infections. Evidence of tuberculosis may include either a
positive tuberculosis blood test (by a positive QuantiFERON® TB-Gold test or a
positive tuberculin skin test) or chest X-ray radiographic findings consistent with
active or latent tuberculosis.

Cardiovascular Exclusions

30. Supine sustained (i.e. 3 independent measurements within 30 min) systolic blood
pressure greater than 140 or less than 90 mmHg.

31. Supine sustained (i.e. 3 independent measurements within 30 min) diastolic blood
pressure greater than 90 or less than 40 mmHg.

32. Sustained (i.e. 3 independent measurements within 30 min) heart rate (pulse) greater
than 100 or less than 40 beats per minute (bpm).

33. QTcF < 300 msec or = 450 msec.

34. Personal and/or family history of congenital long QT syndrome or sudden cardiac death

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network- Centre for Clinical Studies - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alpine Immune Sciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Clinical Network Services (CNS) Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is testing the safety, tolerability, pharmacokinetics (PK--the amount of study
drug in the blood), pharmacodynamics (PD), how the study drug affects the body) and
immunogenicity (how the study drug affects the immune system) of single and multiple doses
and dose levels of an investigational drug called ALPN-101.
Trial website
https://clinicaltrials.gov/show/NCT03748836
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Steven Yau, BSc(Hons), PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 8593 8919
Fax 0 0
Email 0 0
s.yau@nucleusnetwork.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03748836