GL-0719 - A Phase 1, Double-blind, Placebo-controlled, Single Ascending Intravenous and Subcutaneous Injection Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and an Open-label Evaluation of Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Healthy female or male subjects who, at the time of screening, are between the ages of 18 and 65 years, inclusive.

• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.

• 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.

• 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.

• The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.

• Female or male subjects who, at the time of screening, are at least 18 years of age with a total body weight of ≥ 50 kg.

• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.

• The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.

• The subject must be willing to return to the study center for study treatment and study-related follow-up procedures as required by the protocol.

• 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.

• The Participant Identification Center (PIC) site will have provided evidence that the PIC site used to confirm diagnosis of Cold Agglutinin Disease (CAD)

• Primary Cold Agglutinin Disease (CAD) or CAD secondary to active lymphoid or other hematologic malignancy (Cold Agglutinin Syndrome).

• Hemoglobin level \< 105 gram per liter (g/L).

• Bilirubin level above the normal reference range.

Locations
Other Locations
United Kingdom
Fortrea Clinical Research Unit Ltd
RECRUITING
Leeds
Contact Information
Primary
Gliknik Clinical Trials Group
gliknikclinicaltrialinquiries@gliknik.com
410-665-0662
Time Frame
Start Date: 2022-04-08
Estimated Completion Date: 2026-01-21
Participants
Target number of participants: 70
Treatments
Experimental: GL-0719
Dose level cohorts randomized in a 3:1 ratio to GL-0719 or placebo treatment, respectively.~The study will comprise a single-dose, sequential-group design.~Single Ascending IV Dose Cohorts~* Cohort 1: 4 subjects~* Cohort 2: 8 subjects~* Cohort 3: 8 subjects~* Cohort 4: 8 subjects~* Cohort 5: 8 subjects~Subcutaneous Injection Cohort~* Cohort 6: 8 subjects~* Cohort 7: 8 subjects~* Cohort 8 (Patient Arm): Up to 6 subjects with Cold Agglutinin Disease (CAD); Placebo is not applicable.~* Cohort 9 (Patient Arm): Up to 12 subjects with Cold Agglutinin Disease (CAD); Placebo is not applicable.
Placebo_comparator: Placebo
Dose level cohorts randomized in a 3:1 ratio to GL-0719 or placebo treatment, respectively.~The study will comprise a single-dose, sequential-group design.~Single Ascending IV Dose Cohorts~* Cohort 1: 4 subjects~* Cohort 2: 8 subjects~* Cohort 3: 8 subjects~* Cohort 4: 8 subjects~* Cohort 5: 8 subjects~Subcutaneous Injection Cohort~* Cohort 6: 8 subjects~* Cohort 7: 8 subjects
Sponsors
Leads: Gliknik Inc.

This content was sourced from clinicaltrials.gov