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Effect of TPN171H on Spermatogenesis

Sponsor
Vigonvita Life Sciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05585931
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
4.5
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a phaseⅠstudy to determine the acute effects of TPN171H on semen function in healthy male subjects.

Condition or Disease Intervention/Treatment Phase
  • Drug: TPN171H 10mg
  • Drug: TPN171H Placebo
 Phase 1

Detailed Description

Safety Study in male subjects

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluate the Acute Effects of a Single Oral Dose of TPN171H on Semen Function in Healthy Male Subjects in China
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

9 subjects receive 10 mg TPN171H for Period 1; Placebo for Period 2

Drug: TPN171H 10mg
Subjects were given 10mg TPN171H tablet with 240 mL warm water under fasting condition.

Drug: TPN171H Placebo
Subjects were given Placebo with 240 mL warm water under fasting condition.
Experimental: Cohort 2

9 subjects receive Placebo for Period 1; 10 mg TPN171H for Period 2

Drug: TPN171H 10mg
Subjects were given 10mg TPN171H tablet with 240 mL warm water under fasting condition.

Drug: TPN171H Placebo
Subjects were given Placebo with 240 mL warm water under fasting condition.

Outcome Measures

Primary Outcome Measures

  1. Effect on semen function [1.5 hours after taking the medicine]

    The parameters of semen routine analysis were compared between TPN171H tablets and placebo.

  2. Seminal plasma exposure [1.5 hours after taking the medicine]

    TPN171H exposure in seminal fluid

Secondary Outcome Measures

  1. Adverse events [From administration of study drug through 3 days after last administration of study drug]

    adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Male aged 18~40years (included)

  2. Body Mass Index of 19 to 28 kg/m2; Body weight no less than 50 kg;

  3. Sperm concentration ≥15*10^6/ml, Sperm motility(a+b(%))≥32%, Semen volume ≥1.5 ml, Liquefaction time≤60 min

  4. Sperm sample should be collected after a minimum of 2 days and a maximum of 7 days of sexual abstinence.

  5. Take reliable contraceptive measures

  6. Physical examination, vital signs examination, laboratory examination, ECG were normal or abnormal without clinical significance;

  7. Be able to understand and willing to sign the Informed Consent Form;

Exclusion Criteria:

  1. People with azoospermia, teratozoospermia, moderate-to-severe asthenozoospermia, and moderate-to-severe oligozoospermia and other abnormal semen disease

  2. People with vasectomy and ligation

  3. People who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H;

  4. There are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;

  5. Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;

  6. A history of fainting needles or fainting blood;

  7. Blood loss or blood donation of 400 mL or more within 3 months before administration;

  8. Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration

  9. those who have participated in other drug clinical trials and received trial drugs within 3 months before

  10. Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);

  11. Urine drug screening positive；

  12. Smoking more than 10 cigarettes per day ；

  13. Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;

  14. he investigator believes that there are other factors that are not suitable for participating in this trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University First Hospital Beijing Beijing China 100032

Sponsors and Collaborators

  • Vigonvita Life Sciences

Investigators

  • Principal Investigator: Hui Jiang, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vigonvita Life Sciences
ClinicalTrials.gov Identifier:
NCT05585931
Other Study ID Numbers:
  • TPN171H-12
First Posted:
Oct 19, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Erectile Dysfunction

Study Results

No Results Posted as of Dec 7, 2022