IBIO-600: testing a single dose in adults who are overweight or obese

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single ascending dose study evaluating IBIO-600 versus placebo in adults aged 18-65 with BMI 27-34.9. Participants are monitored for safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity, along with changes in body composition and physical function over about 9 months. The trial aims to identify a dose with an acceptable safety profile and potential signals of biological activity related to weight-related outcomes. Enrollment is at Veritus Research in Bayswater, Australia, under the lead sponsor iBio, Inc. No other collaborators are listed.

Why it matters

Who can join: the full rules

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).

Where it's running

• Veritus Research
  Bayswater, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Cory Schwartz, PhD
• Email: IBIO-600-CT001@ibioinc.com
• Phone: 979-446-0027

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.