# Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease

> **NCT05318534** · PHASE1 · RECRUITING · sponsor: **Gliknik Inc.** · enrollment: 70 (estimated)

## Conditions studied

- First in Man Study to Evaluate Initial Safety

## Interventions

- **DRUG:** GL-0719
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05318534
- **Lead sponsor:** Gliknik Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2022-04-08
- **Primary completion:** 2026-06-30
- **Final completion:** 2026-06-30
- **Target enrollment:** 70 (ESTIMATED)
- **Last updated:** 2026-03-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05318534

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05318534, "Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease". Retrieved via AI Analytics 2026-07-04 from https://api.ai-analytics.org/clinical/NCT05318534. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*