A phase 1, randomized, double blind, placebo-controlled, single ascending dose study to assess safety, tolerability and pharmacokinetics of cRGD-ZW800-1 intravenous injection in healthy volunteers

A phase 1, randomized, double blind, placebo-controlled, single ascending dose study to assess safety, tolerability and pharmacokinetics of cRGD-ZW800-1 intravenous injection in healthy volunteers - A phase 1 study of cRGD-ZW800-1 in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43465

Enrollment

Registered

2016-02-25

Start date

2017-04-03

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Cancer Malignant tumors

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. The subject is 18-65 years old at screening. 2. The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed. 3. Female subjects need to be either surgically sterile, post-menopausal or pre-menopausal with a negative urine pregnancy test at screening and just before administration of cRGD-ZW800-1. Pre-menopausal female subjects who are not surgically sterile should also employ an effective method of birth control for at least 90 days post dosing when it consists of a hormonal contraceptive method or IUD. For other contraceptive methods premenopausal females who are not surgically sterile have to agree to use an effective method of contraception. 4. The subject*s body weight is

Exclusion criteria

Exclusion criteria: 1. Female subjects that are lactating or pregnant. 2. Unacceptable known diagnoses or diseases at baseline, e.g., known cardiovascular or pulmonary disease, renal or liver dysfunction, ECG or laboratory abnormalities, etc. 3. Use of prescription drugs, with the exception of contraceptive drugs. 4. Previous inclusion in this study. 5. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year. 6. History of anaphylactic reactions.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability is the primary endpoint of the study. This will be assessed from data on the occurrence of treatment-emergent adverse events (TEAEs) from the time of administration throughout the study period, and changes in serum biochemistry, hematology, urinalysis, vital signs, ECG, injection site status, and physical examination findings. In addition, analysis of the PK of cRGD-ZW800-1 will be conducted.	—

Measure

Time frame

Safety and tolerability is the primary endpoint of the study. This will be assessed from data on the occurrence of treatment-emergent adverse events (TEAEs) from the time of administration throughout the study period, and changes in serum biochemistry, hematology, urinalysis, vital signs, ECG, injection site status, and physical examination findings. In addition, analysis of the PK of cRGD-ZW800-1 will be conducted.

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Countries

Netherlands

Outcome results