A Research Study Looking at the Safety of Single and Multiple Doses of ZP9830 and How it Works in the Body of Healthy Participants
NCT06682975 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2026-02-17
Summary
The primary object in this research study is to investigate the safety and tolerability of ZP9830 in healthy study participants, and in addition, the study will investigate how ZP9830 works in the body (pharmacokinetics, PK and pharmacodynamics, PD) compared to placebo.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
ZP9830
SAD: Participants will receive 1 single dose of ZP9830 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort. MAD: Participants will receive multiple doses of ZP9830 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort.
- DRUG
-
SAD: Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Volume will be matching the active treatment. MAD: Participants will receive multiple doses of placebo given subcutaneously (s.c., under the skin). Volume will be matching the active treatment.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Zealand Pharma A/S · Zealand Pharma A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-12
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- Netherlands
Study Locations
More Related Trials
-
A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.
NCT02512575 ·Status: COMPLETED ·Phase: PHASE1
-
A Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
NCT04612517 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD8965 in Healthy Participants (Including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants
NCT06502379 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers
NCT05894707 ·Status: UNKNOWN ·Phase: PHASE1
-
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
NCT06103877 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects
NCT02601625 ·Status: COMPLETED ·Phase: PHASE1
-
Сlinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers
NCT06780124 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ND-L02-s0201 Injection in Normal Healthy Subjects
NCT01858935 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of LY2775240 in Healthy Participants
NCT02963779 ·Status: COMPLETED ·Phase: PHASE1
-
ZD03 Capsule Study
NCT04693455 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Escalating Study of HC002 in Healthy Adult Volunteers
NCT06670274 ·Status: COMPLETED ·Phase: PHASE1
-
The Safety and Tolerability of STSA-1005 Following Intravenous Infusion in Healthy Subjects
NCT05085197 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Participants
NCT02623491 ·Status: COMPLETED ·Phase: PHASE1
-
A Single and Multiple-Dose Study of SB1578
NCT01235871 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR8020 in Japanese Healthy Participants
NCT02015533 ·Status: WITHDRAWN ·Phase: PHASE1
-
Single and Multiple Ascending Dose Study and Food Effect Study for AG181
NCT06286033 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects
NCT00972049 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy People
NCT07029568 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
NCT05928585 ·Status: COMPLETED ·Phase: PHASE1
-
AZD5985 Single Ascending Dose Study
NCT00967356 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants
NCT02758392 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject
NCT06389942 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject
NCT05398510 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of STSA-1201 in Healthy Subjects
NCT05986877 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers
NCT04857866 ·Status: COMPLETED ·Phase: PHASE1