Cancer Survivors, Healthy Participant, Elderly Other
Conditions
Interventions
The dose of randomisation is 0.02 mg/kg of GI-102. The method of randomisation is centralized, stratified randomization (stratification based on geographic location
Australia versus South Korea). Site staff will be notified of the participant’s group assignment on Day 1.
1) Active Comparator: Part A
- GI-102 in combination with GIB-7
- Combination Product: GI-10
* GIB-7: synbiotic formula, oral administration, once daily (QD)
Other Names:
• efzilonkofusp alfa in combination with GIB-7
2) Active Comparator: Part B Arm 1
- GI-102 in combination with GIB-7
- Co
* GIB-7: synbiotic formula, oral administration, once daily (QD)
Other Names:
• efzilonkofusp alfa in combination with GIB-7
3) Placebo Comparator: Part B Arm 2
- Placebo for GI-102 (normal saline) i
Sponsors
GI Innovation, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Must be aged between =18 and =80 years old at the time of informed consent 2. At the discretion of the Investigator, must be in a state of general health that is not severely compromised (ie, no life-threatening illness or disability) 3. Participants with a history of cancer may be included only if they meet one of the following: 3.1. They have been disease-free for =2 years; OR 3.2. For those diagnosed within 2 years: 3.2.1. The cancer was treated with curative intent (eg, surgery, anti-cancer agents, including chemotherapy) 3.2.2. They have been in remission for =12 months 3.2.3. They are not on any active cancer treatment except maintenance therapies (eg, endocrine therapy or bisphosphonates) 3.2.4. They must have received systemic anti-cancer therapies without immunotherapy for their cancers 4. Women of childbearing potential (WOCBP) must agree to use 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 must agree to use an acceptable method of contraception from 14 days prior to Visit 2 until 90 days after the last dose of study medication (GI-102 or GIB-7).
Exclusion criteria
Exclusion criteria: 1. Severe and poorly managed chronic diseases, such as advanced cardiovascular disease, kidney failure requiring transplant or dialysis, uncontrolled diabetes, detectable malignancy (= 2 years), severe chronic obstructive pulmonary disease (COPD), or untreatable, terminal cancer as judged by the Investigator or history of life-threatening infection (eg, meningitis). 2. Dependent on walkers or wheelchairs; severe difficulty or inability to perform activities of daily living independently or inability to perform study measures required to test muscle function (an amputee is eligible if they can walk without walkers or wheelchairs) as judged by the Investigator. 3. Major surgery within the past 6 months or scheduled during the study period, including severe orthopedic diseases requiring joint replacement surgery. 4. History of substance abuse or dependency or history of recreational IV drug use over the last 5 years (by self-declaration). 5. Female participants who are pregnant, planning to become pregnant, or breastfeeding during the study period. Participants undergoing perimenopause or the menopause transition are eligible.
Countries
Australia, Korea, South
Contacts
Public ContactKaren Hwang
Outcome results
None listed