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 range18 Years – 45 Years

SexALL

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
✕1. The urine drug screen is negative
✕2. Breathalyzer test is negative
✕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.

What they're measuring

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

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

The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit

Timeframe: day 0 to day 120

The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit

Timeframe: day 0 to day 180

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

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 180

Trial details

NCT IDNCT04171115

SponsorAlachua Government Services, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-20

Results submitted2024-06-26

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range18 Years – 45 Years

SexALL

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
✕1. The urine drug screen is negative
✕2. Breathalyzer test is negative
✕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.

What they're measuring

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

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

The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit

Timeframe: day 0 to day 120

The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit

Timeframe: day 0 to day 180

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

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 180