Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects (NCT04171115) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
United States40 participantsStarted 2020-06-01
Plain-language summary
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg).
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed consent understood and signed
. Healthy male or healthy, non-pregnant, non-lactating female
. Willingness to comply and be available for all protocol procedures
. Between 18 and 45 years of age on the day of IM injection
. Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2
. If the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to IM injection
. If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception during participation in the study
. The hemoglobin, platelet count, white blood cell count and absolute neutrophil count are not below the LLN and ≤ULN x 10%
Exclusion criteria
. The urine dipstick results on protein, glucose and blood are negative or trace
0. Chemistry screening laboratory tests as outlined in Section 7.5.1.4 are in the normal reference range
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit.
Timeframe: day 0 to day 120
2
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit.
Timeframe: day 0 to day 180
3
The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit
Timeframe: day 0 to day 120
4
The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit
Timeframe: day 0 to day 180
5
The Occurrence of Changes From Baseline in Physical Examination, Vital Signs and Clinical Safety Laboratory Values Following Administration of G03-52-01 to the Final Follow-up Visit.
Timeframe: day 0 to day 120
6
The Occurrence of Changes From Baseline in Physical Examination, Vital Signs and Clinical Safety Laboratory Values Following Administration of G03-52-01 to the Final Follow-up Visit.
3. Available for follow-up for the duration of the study
4. Agrees not to participate in vigorous activity 72 hours prior to dosing through day 15 post dosing
. History of a chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject.
. History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.