A Clinical Trial to Study Single- and Multiple- Doses of GSM-779690T in Healthy Participants

Inclusion Criteria

• •1. Healthy, cognitively typical, and aged 20-45 years (inclusive).
• •2. Current Mini Mental State Examination (MMSE) score between 27 and 30 (inclusive) at screening.
• •3. Able to provide their own written informed consent.
• •4. Able to read, speak and understand English to ensure compliance with cognitive testing and study visit procedures.
• •5. Must be ambulatory and be willing to remain domiciled in the clinic for the required study procedures.
• •6. Contraception requirements:
• •a. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control (confirmed by the investigator) from enrollment, throughout the study duration, at 1 week after last dose of study treatment, and have a negative pregnancy test result at screening. Highly effective methods of birth control (those that can achieve a failure rate of less than 1% per year when used consistently and correctly) include: (i) Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal, (ii) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable, (iii) Intrauterine device, (iv) Intrauterine hormone-releasing system, (v) Bilateral tubal occlusion, (vi) Sexual abstinence, ie, refraining from heterosexual intercourse (vii) Vasectomised sexual partner (provided that partner is the sole sexual partner of the WOCBP study participants and that the vasectomized partner has received medical assessment of the surgical success).
• •b. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. The following age-specific requirements apply: (i) Women \< 50 years old will be considered postmenopausal if they have been amenorrhoeic for \>12 months following cessation of exogenous hormonal treatment and FSH levels are in the postmenopausal range (\>40 IU/L). Until FSH is documented to be within menopausal range, the patient should be treated as a WOCBP.
• •(ii) Women \> 50 years old will be considered postmenopausal if they have been amenorrhoeic for \>12 months following cessation of all exogenous hormonal treatment.
• •c. Males with childbearing partners must be willing to practice sexual abstinence or use double-barrier protection during study treatment and until 1 week after the last dose of study treatment.
• +34 more criteria