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Pulmonary Arterial HypertensionPhase 1NCT04505137

A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers

A Phase 1 study testing GMA301 Injection in people with Pulmonary Arterial Hypertension, run by Gmax Biopharm Australia Pty Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-centre, randomized, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability and PK of GMA301 Injection in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
GMA301 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteAustralia
Study dates
2 Sep 2020to 19 Mar 2021
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Non-smoker (no use of tobacco or nicotine products within 2 months prior to screening) with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. Each cohort will include at least 2 participants of Chinese descent, if possible.
  • Healthy as defined by:
  • The absence of clinically significant illness and surgery within 4 weeks prior to dosing.
  • The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
  • Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 6 months after the last study drug administration:
  • Oral, injected, or implanted hormonal methods of contraception in combination with a barrier method;
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  • Placement of an intrauterine device (IUD) or intrauterine system (IUS) in combination with a barrier method;
  • Sterilized male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) in combination with a barrier method;
  • True abstinence, when this is in line with the subject's preferred and usual lifestyle.
  • Male subjects must agree to avoid causing pregnancy by using a reliable method of birth control during the study and for 6 months after study drug administration and must be willing to use one of the following acceptable contraceptives:
  • Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks or intra-uterine contraceptive device placed since at least 4 weeks;
  • Simultaneous use of a male condom and, for the female partner, a diaphragm or cervical cap.
  • Male subjects (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first study drug administration until at least 6 months after study drug administration.
  • Male subjects must be willing not to donate sperm during the study and for 6 months following study drug administration.
  • Capable of consent.

Who cannot join

  • Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
  • Presence or history of any clinically significant chronic condition of the neurological, respiratory, cardiovascular, gastrointestinal, urogenital, reproductive, musculoskeletal, endocrine system or cancer.
  • Clinically significant (as judged by the investigator) presence of acute illness (e.g., gastrointestinal illness, infection such as influenza, upper respiratory tract infection) upo admission to the study site.
  • Alanine aminotransferase and/or aspartate aminotransferase above the upper limit of normal.
  • Positive urine drug screen or alcohol breath test at screening.
  • Positive pregnancy test at screening.
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  • Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg,or heart rate less than 40 or over 100 bpm) at screening. Up to 2 additional measurements may be taken after an appropriate resting interval (at least 10 minutes) at Screening to confirm eligibility.
  • History of type 1 hypersensitivity or severe cutaneous adverse reaction to any medication, or to any excipient in the formulation, or history of significant atopy.
  • Hemoglobin below lower limit of normal.
  • Women who intend to become pregnant or are lactating.
  • History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (average weekly alcohol intake that exceeds 14 units per week (males) or 7 units (females) per week, or are unwilling to stop alcohol consumption for 24 hours prior to study drug dosing until the completion of the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine;1.5 oz or 45 mL of distilled spirits).
  • History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
  • Use of prescription medications or over-the-counter medications within 7 days prior to study drug administration, with the exception of simple analgesics such as paracetamol and routine vitamins.
  • Donated more than 500 mL of blood within 4 weeks prior to study enrollment, or donated plasma or participated in a plasmapheresis program within 7 days of study drug administration.
  • Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • CMAX Clinical Research

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of A Single Intravenous Dose Of GMA301 Injection In Healthy Volunteers

This study is a single-centre, randomized, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability and PK of GMA301 Injection in healthy subjects. Two sequential dosing cohorts (at ascending dose fashion), each with 6 subjects receiving GMA301 Injection and 2 subjects receiving placebo (total of 16 subjects), will be given single doses. The doses to be administered in the two cohorts will be 1500 mg and 2000 mg respectively, or matching placebo

Read the detailed description

The current study is an extension of the previous study #1010218 (ACTRN12618000121268) to further explore the safety and PK profile of GMA301 injection at higher dosage. The SRC (Safety Review Committee) will be responsible for the assessment of safety, tolerability, and PK data for each dose level and to make decisions with regards to study progression. A Statistical Analysis Plan (SAP) will be written after finalizing the protocol and prior to database lock. The SAP will detail the implementation of all the planned statistical analyses in accordance with the principal features stated in the protocol. Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).

Being tested
GMA301 Injection, GMA301 Placebo Injection
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GMA301 InjectionDrug

    GMA301 Injection administered as a single dose of 1500 mg

  • GMA301 Placebo InjectionOther

    GMA301 Injection without GMA301 administered as a single intravenous dose

  • GMA301 InjectionDrug

    GMA301 Injection administered as a single dose of 2000 mg

Study groups in NCT04505137
Study groupRoleWhat they receive
GMA301 1500mg Or Placebo InjectionExperimentalTwo sentinel subjects (1 active and 1 placebo) will be dosed first and then reaming 6 subjects will dosed within 7 days. The dose to be administered is 1500 mg single Intravenous dose of GMA301 Injection.
Receives: Drug: GMA301 Injection; Other: GMA301 Placebo Injection
GMA301 2000mg Or Placebo InjectionExperimentalTwo sentinel subjects (1 active and 1 placebo) will be dosed first and then reaming 6 subjects will dosed within 7 days. The dose to be administered is 2000 mg single intravenous dose of GMA301 Injection.
Receives: Other: GMA301 Placebo Injection; Drug: GMA301 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    To assess the safety and tolerability of GMA301 Injection following single escalating intravenous (IV) injections in healthy subjects.

    Measured: All AEs (adverse events) will be captured from the time the investigator received the signed ICF (informed consent form) of subjects until study completion ie Day 70

Secondary outcomes (8)

  1. Pharmacokinetics Profile

    PK parameters determined is AUC(0-inf)

    Measured: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70

  2. Pharmacokinetics Profile

    PK parameters determined is AUC(0-t)

    Measured: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70

  3. Pharmacokinetics Profile

    PK parameters determined is C(max)

    Measured: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70

  4. Pharmacokinetics Profile

    PK parameters determined is residual area

    Measured: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70

  5. Pharmacokinetics Profile

    PK parameters determined is T(max)

    Measured: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70

  6. Pharmacokinetics Profile

    PK parameters determined is T(1/2 el)

    Measured: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70

  7. Pharmacokinetics Profile

    PK parameters determined is K(el)

    Measured: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70

  8. Dose for GMA301 Injection for subsequent clinical studies

    To identify appropriate doses of GMA301 Injection for subsequent clinical studies

    Measured: All AEs will be captured from the time the investigator received the signed ICF of subjects until study completion ie Day 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2020
  2. Study start2 Sep 2020
  3. Primary completion19 Mar 2021
  4. Study completion19 Mar 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Two sequential dosing cohorts, each with 6 subjects receiving GMA301 Injection and 2 subjects receiving placebo (total of 16 subjects). The doses to be administered will be 1500 mg and 2000 mg, or matching placebo, single dosing. Each cohort will include at least 2 participants of Chinese descent, if possible.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04505137
Sponsor's protocol ID
GETA_SAD_02
Status last verified
Nov 2020
First submitted
31 Jul 2020
Last updated
1 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GMA301 Injection in people with Pulmonary Arterial Hypertension, run by Gmax Biopharm Australia Pty Ltd. 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 15 inclusion and 16 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 1 Sep 2021. 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. 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 and Tolerability (time frame: All AEs (adverse events) will be captured from the time the investigator received the signed ICF (informed consent form) of subjects until study completion ie Day 70). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04505137.

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 1 Sep 2021.

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