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Recruiting NCT07487376

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults

Phase I Interventional Overweight , Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBIO-600, Placebo.
Who it may be relevant to
Registry conditions: Overweight , Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBIO-600 in Overweight or Obese Adult Participants (IBIO-600-CT001).

Overview

The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.

Detailed description

The study is a single ascending dose study, with participants monitored for 9 months after administration.

This clinical trial will seek to address the following:

* Which dose of the study drug is most effective. * How safe the study drug is and how well participants tolerate it. * How much of the study drug can be found in blood (pharmacokinetics). * How the study drug affects the body (pharmacodynamics). * How the body's immune system responds to the study drug (immunogenicity). * How the body's composition and physical function may change over the course of the study.

Interventions

  • Drug IBIO-600
    IBIO-600 Subcutaneous injection
  • Drug Placebo
    Matching placebo; subcutaneous injection

Primary outcome measures

  • Assessment of the safety and tolerability of a single dose of IBIO-600 [Time frame: From Day 1 through Day 252 (end of study).]
Secondary outcome measures (10)
  • Pharmacokinetics of a single dose of IBIO-600 [Time frame: Baseline up to Week 36]
  • Pharmacokinetics of a single dose of IBIO-600 [Time frame: Baseline up to Week 36]
  • Pharmacokinetics of a single dose of IBIO-600 [Time frame: Baseline to the last measurable concentration (AUC0-last)]
  • Pharmacokinetics of a single dose of IBIO-600 [Time frame: Baseline to infinity (AUC0-inf)]
  • Pharmacokinetics of a single dose if IBIO-600 [Time frame: Baseline up to Week 36]
  • Pharmacokinetics of a single dose of IBIO-600 [Time frame: Baseline through Week 36]
  • Pharmacokinetics of a single dose of IBIO-600 [Time frame: Baseline up to Week 36]
  • Pharmacodynamics (PD) of a single dose of IBIO-600 [Time frame: Baseline through Week 36]
  • Pharmacodynamics of a single dose of IBIO-600 [Time frame: Baseline up to Week 36]
  • Pharmacodynamics of a single dose of IBIO-600 [Time frame: Baseline up to Week 36]

Eligibility criteria

Inclusion criteria

  • Aged 18 to 65 years of age
  • In good general health, with no significant medical history
  • BMI between ≥ 27.0 and ≤ 34.90 kg/m2
  • History of self-reported stable body weight (defined as change of no more or less than ± 5%) within 90 days of Screening.
  • Willingness to refrain from any reconstructive and/or cosmetic surgery and/or non-invasive cosmetic procedure that may affect body weight during the study
  • Must be fully ambulatory without any chronic orthopedic diseases or reliance on crutches, walkers, or a wheelchair that may preclude normal activity.
  • Be a nonsmoker/nonvaper and must not have used any nicotine or synthetic type products within 1 month prior to randomization.
  • Must not be pregnant or breastfeeding
  • Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until study completion, or for a minimum of 9 months following the last dose of IP, whichever period is longer.

Exclusion criteria

  • An underlying physical or psychological medical conditions that, in the opinion of the PI or medical designee, would make the participant unlikely to comply with the protocol or complete the study per protocol.
  • History or active diagnosis of diabetes (Type 1 or 2).
  • History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months).
  • History or presence of clinically significant muscle disease
  • History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension.
  • Clinically significant laboratory abnormalities that would preclude participation in the study.
  • History of malignancy, except for non-melanoma skin cancer excised > 2 years ago or cervical intraepithelial neoplasia successfully treated > 5 years prior to randomization.
  • History or presence of any condition associated with significant immunosuppression.
  • History of substance abuse or dependency, or recreational IV drug use within the past 5 years (self-reported).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Veritus Research — Bayswater

Identifiers

NCT: NCT07487376 · IBIO-600-CT001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗