Healthy VolunteersPhase 1NCT03748836
Adult Healthy Volunteers Study to Evaluate ALPN-101 Safety
A Phase 1 study testing ALPN-101 in people with Healthy Volunteers, run by Alpine Immune Sciences, Inc. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ALPN-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Jan 2019to 18 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to participate and willing to give written informed consent.
- Healthy adult participant 18 to 65 years of age, inclusive, at the time of informed consent.
- BMI between 18 and 30 kg/m2, inclusive.
- 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.
- Female participants must not be pregnant or breastfeeding
Who cannot join
- General Health Exclusions
- 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.
- History or symptoms of significant psychiatric disease in the opinion of the Principal Investigator, including but not limited to depression and schizophrenia.
- History of immunological disorders, auto-immune disorders, acquired or congenital immune deficiency.
- History of significant hepatic or renal disease or impairment.
- 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.
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- History of major organ transplantation with an existing functional graft. Therapeutic and Intervention-Related Exclusions
- 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.
- Any concomitant medications that prolong QT/QTc interval.
- Dosed with an investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to study drug administration.
- Received any systemic steroid within 1 month or systemic immunosuppressant agent within 6 months prior to study drug administration.
- Received any antibody therapy or biologic products within 6 months prior to study drug administration.
- Significant loss of blood including blood donation over 500 mL or transfusion of any blood product within 3 months before the Screening Visit.
- Unwilling to refrain alcohol use 48 hours prior to your admission into the clinical research unit.
- Known hypersensitivity, allergy or intolerance to the study drug or any of the excipient contained in the intervention formulation.
- Immunisation with any vaccine within 6 weeks prior to study drug administration.
- 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
- 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.
- Estimated creatinine CL < 90 mL/minute at the Screening Visit
- 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.
- Positive alcohol breath test at the Screening Visit and/or at baseline.
- 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.
- Positive serum pregnancy test at the Screening Visit or admission to the CRU. Infection-related Exclusions.
- Acute infection including viral infections in the preceding 6 weeks
- 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
- Supine sustained (i.e. 3 independent measurements within 30 min) systolic blood pressure greater than 140 or less than 90 mmHg.
- Supine sustained (i.e. 3 independent measurements within 30 min) diastolic blood pressure greater than 90 or less than 40 mmHg.
- Sustained (i.e. 3 independent measurements within 30 min) heart rate (pulse) greater than 100 or less than 40 beats per minute (bpm).
- QTcF < 300 msec or ≥ 450 msec.
- Personal and/or family history of congenital long QT syndrome or sudden cardiac death
Trial locations and contacts
1 site in 1 country.
Australia1 site
Nucleus Network- Centre for Clinical Studies
Melbourne, Victoria, 3004
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-101 in Adult Healthy Volunteers
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.
Read the detailed description
AIS-A01 is a phase 1, randomized, placebo-controlled, double-blinded study in healthy volunteers. It will be conducted at a single center and will enroll approximately 104 participants. The study will have 2 parts:
- In Part A, participants will receive a single dose of study drug or placebo. Multiple dose levels of ALPN-101 will be evaluated.
- In Part B, participants will receive 4 doses of ALPN-101 or placebo--1 dose each week for 4 weeks. Multiple dose levels of ALPN-101 will be evaluated.
In each Part, safety assessments will be performed throughout the dosing and follow-up periods, and multiple PK and PD samples will be collected.
- Conditions
- Healthy Volunteers
- Being tested
- ALPN-101, Placebo
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPN-101Drug
Single or multiple doses of ALPN-101 delivered via intravenous or subcutaneous injection. Ascending dose levels will be evaluated.
PlaceboDrug
Single or multiple doses of placebo delivered via intravenous or subcutaneous injection, matched to ALPN-101 cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose ALPN-101 | Active comparator | Not described Receives: Drug: ALPN-101 |
| Single Dose Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Multiple Ascending Dose ALPN-101 | Active comparator | Not described Receives: Drug: ALPN-101 |
| Multiple Dose Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as assessed by adverse events according to CTCAE v5.0
The rate of adverse events will be compared between the 2 treatment groups.
Measured: From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4-8 weeks)
Secondary outcomes (4)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start29 Jan 2019
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blinded, dose escalation to evaluate the safety, PK, and PD of single and multiple doses of ALPN-101
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpine Immune Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Network Services (CNS) Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748836
- Sponsor's protocol ID
- AIS-A01
- Status last verified
- Oct 2019
- First submitted
- 5 Nov 2018
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-101 in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03748836
- Acronym / sponsor ID
- AIS-A01
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Alpine Immune Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinical Network Services (CNS) Pty Ltd
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AIS-A01 is a phase 1, randomized, placebo-controlled, double-blinded study in healthy volunteers. It will be conducted at a single center and will enroll approximately 104 participants. The study will have 2 parts:
- In Part A, participants will receive a single dose of study drug or placebo. Multiple dose levels of ALPN-101 will be evaluated.
- In Part B, participants will receive 4 doses of ALPN-101 or placebo--1 dose each week for 4 weeks. Multiple dose levels of ALPN-101 will be evaluated.
In each Part, safety assessments will be performed throughout the dosing and follow-up periods, and multiple PK and PD samples will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, placebo-controlled, double-blinded, dose escalation to evaluate the safety, PK, and PD of single and multiple doses of ALPN-101
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose ALPN-101 | Active comparator | Drug: ALPN-101 |
| Single Dose Placebo | Placebo comparator | Drug: Placebo |
| Multiple Ascending Dose ALPN-101 | Active comparator | Drug: ALPN-101 |
| Multiple Dose Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to participate and willing to give written informed consent.
- Healthy adult participant 18 to 65 years of age, inclusive, at the time of informed consent.
- BMI between 18 and 30 kg/m2, inclusive.
- 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.
- Female participants must not be pregnant or breastfeeding
Key exclusion criteria (31 listed)
- General Health Exclusions
- 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.
- History or symptoms of significant psychiatric disease in the opinion of the Principal Investigator, including but not limited to depression and schizophrenia.
- History of immunological disorders, auto-immune disorders, acquired or congenital immune deficiency.
- History of significant hepatic or renal disease or impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALPN-101Single or multiple doses of ALPN-101 delivered via intravenous or subcutaneous injection. Ascending dose levels will be evaluated. | Drug | Multiple Ascending Dose ALPN-101, Single Ascending Dose ALPN-101 |
| PlaceboSingle or multiple doses of placebo delivered via intravenous or subcutaneous injection, matched to ALPN-101 cohorts. | Drug | Multiple Dose Placebo, Single Dose Placebo |
Primary outcome
Safety, as assessed by adverse events according to CTCAE v5.0
Time frame: From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4-8 weeks)
The rate of adverse events will be compared between the 2 treatment groups.
4 secondary outcomes
Pharmacokinetics of ALPN-101 as assessed by time of maximum ALPN-101 concentration.
Time frame: 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)
Pharmacokinetics of ALPN-101 as assessed by the maximum concentration of ALPN-101.
Time frame: 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)
Pharmacokinetics of ALPN-101 as assessed by AUC on all subjects.
Time frame: 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)
The incidence of ADA against ALPN-101 will be assessed and summarized.
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALPN-101 in people with Healthy Volunteers, run by Alpine Immune Sciences, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, as assessed by adverse events according to CTCAE v5.0 (time frame: From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4-8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.