Blood and Urine Sample Collection From Healthy Volunteers

NCT05154409 | Completed

• 1 other identifier: EVT_CTC_01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to obtain blood and urine samples from healthy volunteers to serve as a healthy control group for cross-cohort comparisons.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Collection of blood samples from healthy volunteers to serve as a healthy control group.

  There are no primary endpoints planned; endpoints will be specified in the individual research projects that will utilize the blood samples as a control group.

  1 day

• Collection of urine samples from healthy volunteers to serve as a healthy control group.

  There are no primary endpoints planned; endpoints will be specified in the individual research projects that will utilize the urine samples as a control group.

  1 day

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers who met all inclusion and none of the exlusion criteria

You may qualify if:

• Healthy male and female subjects aged 40-70 years.
• Caucasian
• Non-smokers or ex-smokers
• Body Mass Index (BMI): ≥18.5 and ≤32 kg/m2
• Presence of a negative SARS-CoV-2 PCR test.

You may not qualify if:

• Complaints that may indicate the presence of an infection, including Covid-19.
• Pathological alcohol consumption.
• Positive alcohol breath test at the preliminary examination.
• Alcohol consumption within the last 24 hours before the start of sampling.
• History of drug dependence.
• Positive urine drug test during the preliminary examination.
• Clinically significant acute or chronic disease. In particular, chronic inflammation, rheumatological and other autoimmune diseases, diabetes and other metabolic diseases.
• Indications in the medical history or during the medical examination that may jeopardize the safety of the study participant by participating in the study.
• History of relevant clinically significant cardiovascular disorders or clinically relevant hyper- or hypotension or clinically relevant brady- or tachycardia at screening as assessed by an investigator.
• Heart rate \<45/min after 5 minutes in a quiet sitting position.
• Heart rate \>100/min after 5 minutes in a quiet sitting position.
• Systolic blood pressure of \> 170 mmHg or \< 90 mmHg.
• Diastolic blood pressure of \> 95 mmHg and/or \< 60 mmHg.
• Presence of clinically significant food intolerance and/or food allergy as assessed by the investigator.
• Medically relevant previous operations.

Sponsors & Collaborators

• Evotec International GmbH: lead

Study Sites (1)

CTC North

Hamburg, 20251, Germany

Location

Study Officials

• Hanna Peradziryi

  Hanna.Peradziryi@evotec.com

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: December 13, 2021
• Study Start: February 22, 2021
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-11

Locations

DE (1)