Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Femal
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in healthy adult male and female subjects. In addition, safety, tolerability, PK, and pilot efficacy
| Condition(s) | First in Man Study to Evaluate Initial Safety |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in healthy adult male and female subjects. In addition, safety, tolerability, PK, and pilot efficacy biomarkers will be evaluated in subjects with cold agglutinin disease (CAD). |
| Who can participate | Inclusion Criteria for Cohorts 1 to 7 1. Healthy female or male subjects who, at the time of screening, are between the ages of 18 and 65 years, inclusive. 2. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. 3. Body mass index of 18.0 to 32.0 kg/m\^2, inclusive; and a total body weight \> 50 kg up to a maximum of 110 kg. 4. Study subjects must have received a quadrivalent meningococcal conjugate vaccine (meningococcal serogroups A, C, W, and Y) within the past 5 years or vaccination a minimum of 14 days prior to initial study drug administration. 5. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent. Inclu |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Gliknik Inc. |
| Locations | Leeds, United Kingdom |
| Start date | 2022-04-08 |
| NCT ID | NCT05318534 |
| Official listing | https://clinicaltrials.gov/study/NCT05318534 |