Phase
Condition
Aging
Treatment
Placebo
GI-102 in combination with GIB-7
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Must be aged between ≥18 and ≤80 years old at the time of informed consent.
At the discretion of the Investigator, must be in a state of general health that isnot severely compromised (ie, no life-threatening illness or disability).
Participants with a history of cancer may be included only if they meet one of thefollowing:
Participants have been disease-free for ≥2 years; OR
For those diagnosed within 2 years:
- The cancer was treated with curative intent (eg, surgery, anti-canceragents including chemotherapy)
- Participants have been in remission for ≥12 months
- Participants are not on any active cancer treatment except maintenancetherapies (eg, endocrine therapy or bisphosphonates)
- Participants must have received systemic anti-cancer therapies withoutimmunotherapy for their cancers
- Women of childbearing potential (WOCBP; see definition in Section 5.3) must agree touse a highly effective method of contraception from 14 days prior to Visit 2 until 180 days after the last dose of study medication (GI-102 or GIB-7). Fertile men mustagree to use an acceptable method of contraception from 14 days prior to Visit 2until 90 days after the last dose of study medication (GI-102 or GIB-7).
Exclusion
Key Exclusion Criteria:
Severe and poorly managed chronic diseases, such as advanced cardiovascular disease,kidney failure requiring transplant or dialysis, uncontrolled diabetes, detectablemalignancy (≤ 2 years), severe chronic obstructive pulmonary disease (COPD), oruntreatable, terminal cancer as judged by the Investigator or history of lifethreatening infection (eg, meningitis).
Dependent on walkers or wheelchairs; severe difficulty or inability to performactivities of daily living independently or inability to perform study measuresrequired to test muscle function (an amputee is eligible if participants can walkwithout walkers or wheelchair) as judged by the Investigator.
Major surgery within the past 6 months or scheduled during the study period,including severe orthopedic diseases requiring joint replacement surgery.
History of substance abuse or dependency or history of recreational IV drug use overthe last 5 years (by self-declaration).
Female participants who are pregnant, planning to become pregnant, or breastfeedingduring the study period. Participants undergoing perimenopause or the menopausetransition are eligible.
Study Design
Study Description
Connect with a study center
Novatrials
Charlestown 2171766, New South Wales 2155400 2290
AustraliaActive - Recruiting
Southern Oncology Clinical Research Unit
Adelaide 2078025, South Australia 2061327 5042
AustraliaActive - Recruiting

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