A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in Healthy Participants.

A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in Healthy Participants. - Multiple Dose Study on Safety, Tolerability, and PK of SRK-001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52159

Enrollment

Registered

2021-09-22

Start date

2021-11-23

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLE systemic lupus erythematosus

Interventions

The volunteer will receive the study drugs as an intravenous infusion (solution of the drug administered directly into a blood vessel). Each infusion takes approximately 30 minutes. Whether the vol

We call this a double-blind study. If it is important for health, for example in the case of a serious side effect, this can be looked up. Groups 1, 1a and 3: The volunteer receives 300 milligrams

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Participant must be 18 to 65 years of age at the time of signing the informed consent. 2. Participants who have clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment 3. Body mass index of 18 to 32 kg/m2, inclusive 4. Healthy male participants a. Nonvasectomized male participants must agree to abstain from sexual intercourse or use a condom as well as 1 additional highly effective method of contraception (

Exclusion criteria

Exclusion criteria: 1. Have any concomitant disorder that, in the opinion of the investigator, would preclude participation in the study. 2. For at least 30 days prior to randomization, participants must have no symptoms and/or signs of confirmed or suspected infection (including COVID-19) and must have completed any appropriate anti-infective treatment. 3. Have human immunodeficiency virus (HIV) infection. 4. Have a current infection with hepatitis B virus (HBV) (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA. 5. Have a current infection with hepatitis C virus (HCV) (that is, positive for HCV RNA). Further criteria apply, see protocol.

Design outcomes

Primary

Measure	Time frame
TEAEs and SAEs.	—

Secondary

Measure	Time frame
• AUC0-tau at steady state • Half-life (t1/2) • Concentrations at end of infusion (Cmax) and end of dosing interval (Ctrough)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)