Effect of TPN171H on Spermatogenesis

NCT05585931 | Completed Phase 1

• 1 other identifier: TPN171H-12
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• Effect on semen function

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

  1.5 hours after taking the medicine

• Seminal plasma exposure

  TPN171H exposure in seminal fluid

  1.5 hours after taking the medicine

Secondary Outcomes (1)

• Adverse events

  From administration of study drug through 3 days after last administration of study drug

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: TPN171H 10mg; Drug: TPN171H Placebo

Cohort 2

EXPERIMENTAL

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

Drug: TPN171H 10mg; Drug: TPN171H Placebo

Interventions

TPN171H 10mg DRUG

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

Cohort 1; Cohort 2

TPN171H Placebo DRUG

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

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male aged 18\~40years (included)
• Body Mass Index of 19 to 28 kg/m2; Body weight no less than 50 kg;
• Sperm concentration ≥15\*10\^6/ml, Sperm motility(a+b(%))≥32%, Semen volume ≥1.5 ml, Liquefaction time≤60 min
• Sperm sample should be collected after a minimum of 2 days and a maximum of 7 days of sexual abstinence.
• Take reliable contraceptive measures
• Physical examination, vital signs examination, laboratory examination, ECG were normal or abnormal without clinical significance;
• Be able to understand and willing to sign the Informed Consent Form;

You may not qualify if:

• People with azoospermia, teratozoospermia, moderate-to-severe asthenozoospermia, and moderate-to-severe oligozoospermia and other abnormal semen disease
• People with vasectomy and ligation
• People who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H;
• 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;
• 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;
• A history of fainting needles or fainting blood;
• Blood loss or blood donation of 400 mL or more within 3 months before administration;
• Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration
• those who have participated in other drug clinical trials and received trial drugs within 3 months before
• 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);
• Urine drug screening positive；
• Smoking more than 10 cigarettes per day ；
• Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
• he investigator believes that there are other factors that are not suitable for participating in this trial.

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (1)

• Yang Y, Zhang Z, Li L, Jiang Z, Juan J, Duan H, Wang Z, Jiang H. Evaluation of the acute effects of single-dose TPN171 on semen quality in healthy Chinese male volunteers. Br J Clin Pharmacol. 2025 Aug;91(8):2401-2408. doi: 10.1002/bcp.70049. Epub 2025 Apr 3.

  PMID: 40181588 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Hui Jiang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: October 19, 2022
• Study Start: November 15, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)