Assessment of the Safety, Tolerability, and Pharmacokinetic of GMA106

NCT05054530 | Completed Phase 1

• 1 other identifier: GMA106-I-101
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single centre, Phase 1, placebo-control, randomized, double-blind, sequential single and multiple ascending dose study to assess the safety, tolerability, and PK of GMA106 in healthy, overweight or obese subjects.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Nature, incidence and severity of treatment emergent adverse events

  Safety \& Tolerability of GMA106 of Healthy subject in SAD cohort

  up to 150±5 days post injection

• Nature, incidence and severity of treatment emergent adverse events

  Safety \& Tolerability of GMA106 of overweight or obese subject in MAD cohort

  up to 227±5 days post first injection

Secondary Outcomes (6)

• Pharmacokinetic (PK) profile of GMA106 and GMA106 total antibody following single SC administration in healthy subjects.

  Up to 30±1 day for GMA106 and up to 150±5 days post injection for GMA106 total antibody

• Pharmacokinetic (PK) profile of GMA106 and GMA106 total antibody following multiple SC administration in overweight or obese subjects.

  Up to 107±3 day for GMA106 and up to 227±5 days post the first injection for GMA106 total antibody

• Pharmacokinetic (PK) profile of GMA106 and GMA106 total antibody following single SC administration in healthy subjects.

  Up to 30±1 day for GMA106 and up to 150±5 days post injection for GMA106 total antibody

• Pharmacokinetic (PK) profile of GMA106 and GMA106 total antibody following multiple SC administration in overweight or obese subjects.

  Up to 107±3 day for GMA106 and up to 227±5 days post the first injection for GMA106 total antibody

• Pharmacokinetic (PK) profile of GMA106 and GMA106 total antibody following single SC administration in healthy subjects.

  Up to 30±1 day for GMA106 and up to 150±5 days post injection for GMA106 total antibody

Study Arms (2)

GMA106

EXPERIMENTAL

9 different dosages will be subcutaneously injected into the abdomen.

Drug: GMA106 Injection

Matching placebo

PLACEBO COMPARATOR

9 different dosages will be subcutaneously injected into the abdomen.

Drug: GMA106 Matching Placebo

Interventions

GMA106 Injection DRUG

GMA106 solution for injection. Subjects in each cohort will receive a single injection of GMA106 or matching placebo under fasting conditions and at the following target dose levels.

Also known as: GMA106

GMA106

GMA106 Matching Placebo DRUG

Matching Placebo for GMA106

Also known as: Matching placebo for GMA106

Matching placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• SAD:
• Subjects must meet all of the following criteria:
• Male or female.
• ≥ 18 and ≤ 60 years of age.
• BMI \> 20.0 and \< 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
• Non-smoker or light-smoker (≤5 cigarettes or equivalent of nicotine per day within 2 months) prior to screening. A Light smoker must agree to abstain from smoking from screening until after the last PK blood sample collection for GMA106 (Day 30±1), ≤5 cigarettes or equivalent of nicotine are permitted after that.
• Healthy conditions are defined as:
• The absence of currently significant illness and surgeries, within 4 weeks prior to study drug administration.
• The absence of disease history, such as diseases of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and chronic condition of the urogenital, reproductive, musculoskeletal, endocrine systems, or cancer history.
• On top of at least one contraceptive method used by his or her partner, male or female subjects must agree to use at least one contraceptive method throughout the study period, except total abstinence from heterosexual intercourse (when this is in line with the preferred and usual lifestyle of the subjects).
• Female subjects with childbearing potential must agree to use at least one of the following contraceptive methods throughout the study period:
• On top of condom used by her male partner, in case of a female subject who likes to use hormonal contraceptives, the hormone must be used 4 weeks prior to study drug administration.
• On top of condom used by her male partner, in case of a female subject who likes to use intra-uterine contraceptive device, the device must be placed at least 4 weeks prior to study drug administration.
• On top of condom used by her male partner, in case of a female subject who likes to use diaphragm or cervical cap, the method must be started at least 21 days prior to study drug administration.
• \* Contraceptive requirements for women of non-childbearing potential are defined as:

You may not qualify if:

• SAD:
• Subjects who meet any of the following criteria will be excluded from the study:
• Any clinically significant (in the opinion of the Investigator) abnormality at physical examination, abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening. Abnormal laboratory values will include: liver function tests (LFTs) \> 1.5x ULN
• Clinically significant (in the opinion of the Investigator) presence of acute illness (e.g., gastrointestinal illness, gall bladder disease \[cholecystectomy is allowed\], chronic pancreatitis, infection such as influenza, upper respiratory tract infection) upon admission to the study site.
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
• History of renal impairment or renal disease and/or estimated glomerular filtration rate ≤ 90 mL/min (as calculated by Cockroft and Gault formula).
• Positive urine drug screen, or alcohol breath test at screening or at admission, positive urine cotinine test at admission.
• Positive pregnancy test at screening or at admission.
• Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 50 or over 95 mmHg, or heart rate less than 45 or over 100 bpm) at screening.
• 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.
• 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 10 units per week, or are unwilling to stop alcohol consumption for 24 hours prior to study treatment administration until the last PK sample collection of GMA106 of the study on Day 30±1 (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 or 5 x T1/2 whichever is longer prior to dosing, administration of a biological product in the context of a clinical research study within 90 days or 5 x T1/2 whichever is longer prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
• Use of medications for the timeframes specified below, with the exception of hormonal contraception, medications exempted by the Investigator on a case-by- case basis because they are judged unlikely to affect the pharmacokinetic profile of the study treatment or subject safety (e.g., topical drug products without significant systemic absorption):

Sponsors & Collaborators

• Gmax Biopharm Australia Pty Ltd.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sepehr Shakib, Prof

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be double-blinded. The subjects and the clinical personnel involved in the collection, monitoring, revision, or evaluation of adverse events, or personnel who could have an impact on the outcome of the study will be blinded with respect to the subject's treatment assignment (GMA106 Injection or GMA106 placebo Injection)
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 - divided in 2 stages: The 1st stage: single ascending dose (SAD) The 2nd stage: multiple ascending doses (MAD)

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 23, 2021
• Study Start: November 11, 2021
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

AU (1)